Director/Sr. Director, Analytical Development and Quality Control
Director/Sr. Director, Analytical Development and Quality Control
RemeGen Biosciences
Pennsylvania, United States
See who RemeGen Biosciences has hired for this role
KEY RESPONSIBILITIES
- Designscientific approaches and usebest industry practices in support of method transfers and method validations while maintaining compliance with GMP guidelines at all times.
- Writeand reviewrelated CMC sections for the company’s IND and BLA filings.
- Leadestablishment of specifications for in-process controls, drug substances and drug products.
- Workclosely with Analytical Development, Manufacturing, Quality Control, Regulatory, and Quality Assurance to ensure successful tech transfers and validations.
- Maintaina current awareness about biologics development and associated drug/device combinations.
- Ensurethe timely preparation, review, and approval of technical reports, monographs, appropriate sections of regulatory submissions, etc.
- Applytechnical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.
- Buildand maintainstrong working relationships with relevant internal and external stakeholders as well as partner companies, ensuring that activities are managed collaboratively, efficiently and effectively.
Experience:
10+ years in one of the CMC functions with a proven track records of moving biologics products through the approval process. Demonstrated knowledge, experience, and successful track records in leading analytical development or quality control functions. Candidates must have exposure to late phase development, be conversant with good manufacturing practices and have a working knowledge of ICH guidelines.
Skills:
- Possesses a broad technical experience/expertise across the following disciplines: large molecule characterization, mAb formulation/product development, large molecule analytical method development/testing, specification setting for antibody, fusion protein and/or antibody-drug conjugates (ADC) products.
- Sound understanding of CMC regulatory requirements for biologics and direct experience with compiling CMC sections for IND and BLA. Previous active participation in writing and reviewing of CMC sections of regulatory submissions.
- Excellent written and verbal communication skills. Team-oriented, progressive thinker with a can-do attitude who enjoys participating in an innovative and creative work environment.
- Bilingual in Chinese is a plus.
COMPENSATION & BENEFITSSalary Range:Benefits:
- 401(k) and matching program
- Medical, Vision, and Dental Insurance
- Flexible Spending Account
- Short- and long-term disability
- Life insurance
- Employee Assistance Program
- Employee discounts
- Paid time off/vacation/sick time
- Professional development assistance
- Referral program
Must be able to work legally in the United States without sponsorship from employer.
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Seniority level
Director -
Employment type
Full-time -
Job function
Other -
Industries
Biotechnology
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